Systems, methods, and devices for evaluating lead placement based on patient physiological responses

ABSTRACT

An electrical stimulation is applied to a patient via a lead by increasing a stimulation parameter over time. An anal sphincter response, a bellows response, and a toes response from the patient are detected as a result of the electrical stimulation. A first value of the stimulation parameter associated with the anal sphincter response, a second value of the stimulation parameter associated with the bellows response, and a third value of the stimulation parameter associated with the toes response are determined. A placement of the lead inside the patient is evaluated based on: a chronological occurrence of the anal sphincter response, the bellows response, and the toes response; a comparison of the first value with a predetermined threshold; a deviation of the second value from the first value; a deviation of the third value from the first value; or a deviation of the third value from the second value.

PRIORITY DATA

The present application is a Divisional application of U.S. patentapplication Ser. No. 15/043,954, filed on Feb. 15, 2016, which is autility application of provisional U.S. Patent Application No.62/181,827, filed on Jun. 19, 2015, and a utility application ofprovisional U.S. Patent Application No. 62/173,118, filed on Jun. 9,2015, the disclosures of which are hereby incorporated by reference intheir respective entireties.

BACKGROUND

The invention relates to a stimulation system, such as a pelvic nerve orsacral nerve stimulation system, having a tool for programming anelectrical stimulation generator, such as an implantable pulse generator(IPG), of the system.

A sacral nerve stimulator is a device used to provide electricalstimulation to the pelvic region of a patient, for example the sacralnerve or the pudendal nerve, in order to treat problems such asincontinence. The stimulator includes an implanted or external pulsegenerator and an implanted stimulation lead having one or moreelectrodes at a distal location thereof. The pulse generator providesthe stimulation through the electrodes via a body portion and connectorof the lead. Stimulation programming in general refers to theconfiguring of stimulation electrodes and stimulation parameters totreat the patient using one or more implanted leads and its attachedIPG. For example, the programming is typically achieved by selectingindividual electrodes and adjusting the stimulation parameters, such asthe shape of the stimulation waveform, amplitude of current in mA (oramplitude of voltage in V), pulse width in microseconds, frequency inHz, and anodic or cathodic stimulation.

Despite recent advances in medical technology, existing sacral nervestimulation methods, systems, and devices still have variousshortcomings. For example, as stimulation delivered to the patient isramped up, the patient may exhibit various physiological responses.However, existing sacral nerve stimulation methods, systems, and deviceshave not been able to evaluate how well the stimulation lead has beenplaced based on the various physiological responses exhibited by thepatient.

Therefore, although existing systems and methods for performing sacralnerve stimulation are generally adequate for their intended purposes,they have not been entirely satisfactory in all respects.

SUMMARY

One aspect of the present disclosure involves an electronic device forprogramming electrical stimulation therapy for a patient. The electronicdevice includes an electronic memory storage configured to storeprogramming instructions; and one or more processors configured toexecute the programming instructions to perform the following steps:programming a pulse generator to generate electrical stimulation totarget a sacral nerve or a pudendal nerve of the patient, the electricalstimulation being delivered via a lead, the electrical stimulation beingapplied by ramping up a stimulation parameter over time; detecting afirst physiological response, a second physiological response, and athird physiological response from the patient as a result of theelectrical stimulation; measuring a first value of the stimulationparameter associated with the first physiological response, a secondvalue of the stimulation parameter associated with the secondphysiological response, and a third value of the stimulation parameterassociated with the third physiological response; and evaluating aplacement of the lead inside the patient based on at least one of: achronological sequence in which the first, second, and thirdphysiological responses occurred, a comparison of the first value with apredetermined threshold, or respective deviations of the second value orthe third value from the first value.

Another aspect of the present disclosure involves a medical system. Themedical system includes: a pulse generator configured to generateelectrical stimulation pulses as a part of an electrical stimulationtherapy for a patient; an implantable lead configured to deliver theelectrical stimulation pulses to the patient; and a portable electronicprogrammer that is telecommunicatively coupled to the pulse generatorthrough a communications link, wherein the portable electronic device isconfigured to perform the following steps: programming the pulsegenerator to generate electrical stimulation to target a sacral nerve ora pudendal nerve of the patient, the electrical stimulation beingdelivered at least in part via the implantable lead, the electricalstimulation being applied by ramping up a stimulation parameter overtime;

detecting a first physiological response, a second physiologicalresponse, and a third physiological response from the patient as aresult of the electrical stimulation; measuring a first value of thestimulation parameter associated with the first physiological response,a second value of the stimulation parameter associated with the secondphysiological response, and a third value of the stimulation parameterassociated with the third physiological response; and evaluating aplacement of the lead inside the patient based on at least one of: achronological sequence in which the first, second, and thirdphysiological responses occurred, a comparison of the first value with apredetermined threshold, or respective deviations of the second value orthe third value from the first value.

Yet another aspect of the present disclosure involves a method ofevaluating a placement of a lead configured to deliver an electricalstimulation therapy for a patient. The method comprises: programming apulse generator to generate electrical stimulation to target a sacralnerve or a pudendal nerve of the patient, the electrical stimulationbeing delivered at least in part via a lead, the electrical stimulationbeing applied by ramping up a stimulation parameter over time; detectinga first physiological response, a second physiological response, and athird physiological response from the patient as a result of theelectrical stimulation; measuring a first value of the stimulationparameter associated with the first physiological response, a secondvalue of the stimulation parameter associated with the secondphysiological response, and a third value of the stimulation parameterassociated with the third physiological response; and evaluating aplacement of the lead inside the patient based on at least one of: achronological sequence in which the first, second, and thirdphysiological responses occurred, a comparison of the first value with apredetermined threshold, or respective deviations of the second value orthe third value from the first value.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure are best understood from the followingdetailed description when read with the accompanying figures. It isemphasized that, in accordance with the standard practice in theindustry, various features are not drawn to scale. In fact, thedimensions of the various features may be arbitrarily increased orreduced for clarity of discussion. In the figures, elements having thesame designation have the same or similar functions.

FIG. 1 is stylized overview of the human nervous system.

FIG. 2A is a diagram illustrating an example sacral implantation of aneurostimulation lead according to various embodiments of the presentdisclosure.

FIG. 2B is a simplified diagram illustrating an implantableneurostimulation system for stimulating nerves according to variousembodiments of the present disclosure.

FIGS. 3A-3B illustrate an example pocket programmer controller inaccordance with one embodiment of the present disclosure.

FIG. 4 is a block diagram of components of the example pocket controllerof FIGS. 3A-3B in accordance with one embodiment of the presentdisclosure.

FIGS. 5A-5B illustrate an example patient programmer charger controllerin accordance with one embodiment of the present disclosure.

FIG. 6 is a block diagram of components of the example patientprogrammer charger of FIGS. 5A-5B in accordance with one embodiment ofthe present disclosure.

FIG. 7 is a block diagram of a clinician programmer according to oneembodiment of the present disclosure.

FIG. 8 is a block diagram of an implantable pulse generator according toone embodiment of the present disclosure.

FIG. 9 is a diagrammatic block diagram of a patient feedback deviceaccording to an embodiment of the present disclosure.

FIGS. 10A and 10B are exterior views of the patient feedback deviceaccording to embodiments of the present disclosure.

FIG. 11A is a side view of a patient-feedback device inserted in themouth of a patient according to an embodiment of the present disclosure.

FIG. 11B is a side view of a patient-feedback device with opticalsensing according to an embodiment of the present disclosure.

FIG. 11C is a side view of a patient-feedback device activated by a footof a patient according to an embodiment of the present disclosure.

FIG. 12 is a simplified block diagram of a medical system/infrastructureaccording to various aspects of the present disclosure.

FIGS. 13-14 illustrate a graphical user interface of an electronicprogrammer for producing and recording various patient physiologicalresponses according to various aspects of the present disclosure.

FIGS. 15-16 are plots illustrating graphical representations of whethercertain physiological responses occur in a desired chronologicalsequence as well as within a set of desired limits according to variousaspects of the present disclosure.

FIG. 17 illustrates a capability of a graphical user interface of anelectronic programmer to generate and display the plots of FIGS. 15-16according to various aspects of the present disclosure.

FIG. 18 illustrates a capability of a graphical user interface of anelectronic programmer to visually indicate problems or potentialproblems with one or more physiological responses according to variousaspects of the present disclosure.

FIG. 19 is a flowchart illustrating a method of evaluating leadplacement based on a set of physiological responses of the patientaccording to various aspects of the present disclosure.

DETAILED DESCRIPTION

It is to be understood that the following disclosure provides manydifferent embodiments, or examples, for implementing different featuresof the invention. Specific examples of components and arrangements aredescribed below to simplify the present disclosure. These are, ofcourse, merely examples and are not intended to be limiting. Variousfeatures may be arbitrarily drawn in different scales for simplicity andclarity.

Before any embodiments of the invention are explained in detail, it isto be understood that the invention is not limited in its application tothe details of construction and the arrangement of components set forthin the following description or illustrated in the following drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways.

The human nervous system includes a complex network of neurologicalstructures that extend throughout the body. As shown in FIG. 1, thebrain interconnects with the spinal cord which branches into thebrachial plexus near the shoulders and the lumbar plexus and sacralplexus in the lower back. The limb peripheral nerves of the arms extenddistally from the brachial plexus down each arm. Similarly, the limbperipheral nerves of the legs extend distally from the lumbar plexus andsacral plexus. A number of the larger limb peripheral nerves areidentified in FIG. 1. As discussed further below, certain aspects of thepresent invention are particularly well suited to stimulation of thepudendal nerves and the sacral nerves, including those identified inFIG. 1.

FIG. 2A is a simplified diagram illustrating implantation of aneurostimulation lead 10. In the example of FIG. 2A, lead 10 is insertedinto body 12 of a patient, and implanted posterior to one of dorsalforamen 14 of sacrum 16. However, lead 10 alternatively may bepositioned to stimulate pudendal nerves, perineal nerves, sacral spinalnerves, or other areas of the nervous system. Lead 10 may be implantedvia a needle and stylet for minimal invasiveness. Positioning of lead 10may be aided by imaging techniques, such as fluoroscopy. In someembodiments, a plurality of stimulation leads may be provided.

FIG. 2B is a diagram illustrating an implantable neurostimulation system19 for stimulating a nerve, such as a sacral nerve, via the lead 10.Neurostimulation system 19 delivers neurostimulation to the sacralnerves or other regions of the nervous system known to treat problemsincluding, but are not limited to: pelvic floor disorders, urinarycontrol disorders, fecal control disorders, interstitial cystitis,sexual dysfunction, and pelvic pain. As shown in FIG. 2B, system 19includes lead 10 and an implantable pulse generator (IPG). In addition,a proximal end of stimulation lead 10 may be coupled to a connectorblock 21 associated with the neurostimulator 20.

In some embodiments, the neurostimulator 20 includes an implantablepulse generator (IPG), and delivers neurostimulation therapy to patient12 in the form of electrical pulses generated by the IPG. In the exampleof FIG. 2B, the neurostimulator 20 is implanted in the upper leftbuttock of patient 12, but it is understood that the neurostimulator 20be implanted at other locations in alternative embodiments.

The lead 10 carries one or more of stimulation electrodes, e.g., 1 to 8electrodes, to permit delivery of electrical stimulation to the targetnerve, such as the sacral nerve. For example, the implantableneurostimulation system 19 may stimulate organs involved in urinary,fecal or sexual function via C-fibers or sacral nerves at the second,third, and fourth sacral nerve positions, commonly referred to as S2,S3, and S4, respectively. In some embodiments, the neurostimulator 20may be coupled to two or more leads deployed at different positions,e.g., relative to the spinal cord or sacral nerves.

The implantable neurostimulation system 19 also may include a clinicianprogrammer 22 and a patient programmer 23. The clinician programmer 22may be a handheld computing device that permits a clinician to programneurostimulation therapy for patient 12, e.g., using input keys and adisplay. For example, using clinician programmer 22, the clinician mayspecify neurostimulation parameters for use in delivery ofneurostimulation therapy. The clinician programmer 22 supports radiofrequency telemetry with neurostimulator 20 to download neurostimulationparameters and, optionally, upload operational or physiological datastored by the neurostimulator. In this manner, the clinician mayperiodically interrogate neurostimulator 20 to evaluate efficacy and, ifnecessary, modifies the stimulation parameters.

Similar to clinician programmer 22, patient programmer 23 may be ahandheld computing device. The patient programmer 23 may also include adisplay and input keys to allow patient 12 to interact with patientprogrammer 23 and implantable neurostimulator 20. In this manner, thepatient programmer 23 provides the patient 12 with an interface forcontrol of neurostimulation therapy by neurostimulator 20. For example,the patient 12 may use patient programmer 23 to start, stop or adjustneurostimulation therapy. In particular, the patient programmer 23 maypermit the patient 12 to adjust stimulation parameters such as duration,amplitude, pulse width and pulse rate, within an adjustment rangespecified by the clinician via the clinician programmer 22.

The neurostimulator 20, clinician programmer 22, and patient programmer23 may communicate via wireless communication, as shown in FIG. 2B. Theclinician programmer 22 and patient programmer 23 may, for example,communicate via wireless communication with neurostimulator 20 using RFtelemetry techniques known in the art. The clinician programmer 22 andpatient programmer 23 also may communicate with each other using any ofa variety of local wireless communication techniques, such as RFcommunication according to the 802.11 or Bluetooth specification sets,or other standard or proprietary telemetry protocols. It is alsounderstood that although FIG. 2B illustrates the patient programmer 22and the clinician programmer 23 as two separate devices, they may beintegrated into a single programmer in some embodiments.

The various aspects of the present disclosure will now be discussed inmore detail below.

FIGS. 3A-3B, 4, 5A-5B, and 6 illustrate various example embodiments ofthe patient pocket programmer 22 (hereinafter referred to as patientprogrammer for simplicity) according to various aspects of the presentdisclosure. In more detail, FIGS. 3A-3B, 4 are directed to a patientprogrammer that is implemented as a pocket controller 104, and FIGS.5A-5B and 6 are directed to a patient programmer that is implemented asa patient programmer charger (PPC) 106.

Referring now to FIGS. 3A and 3B, the pocket controller 104 comprises anouter housing 120 having an on-off switch 122, a user interfacecomprising a plurality of control buttons 124, and a display 126. Inthis embodiment, the housing 120 is sized for discreetness and may besized to fit easily in a pocket and may be about the same size as a keyfob. In one example, the housing 120 forming the pocket controller 104has a thickness of less than about 1.5 inch, a width of less than about1.5 inch, and a height of less than about 3 inches. In another example,the housing 120 forming the pocket controller 104 has a thickness ofabout 0.8 inch, a width of about 1.4 inch, and a height of about 2.56inch. However, both larger and smaller sizes are contemplated.

In this example, the control buttons 124 include two adjustment buttons128 a, 128 b, a select button 130, and an emergency off button (notshown, but disposed on a side of the housing 120 opposing the on-offswitch 122). The two adjustment buttons 128 a, 128 b allow a user toscroll or highlight available options and increase or decrease valuesshown on the display 126. The select button 130 allows a user to enterthe value or select the highlighted options to be adjusted by actuationof the adjustment buttons 128 a, 128 b. In this example, the buttons 128a, 128 b are used to navigate to one of the three availablefunctions: 1) electrical stimulation on/off, 2) control stimulationamplitude adjustment, and 3) electrical stimulation program selection.Once the desired function is highlighted, the select button is pushed toallow changes (i.e. change the stimulation amplitude, select a differentstimulation program, or turn the electrical stimulation on or off). Insome examples, the IPG control functions of the pocket controller 104consist of these functions. The emergency off button is disposed foreasy access for a patient to turn off stimulation from the IPG 102 ifthe IPG provides too much stimulation or stimulation becomesuncomfortable for the patient. Allowing the user to scroll through theplurality of options (also referred to herein as operational parameters)that can be adjusted via the pocket controller 104 provides the user theconfidence to carry only the pocket controller 104 while away from home.Users may be reluctant to carry only a conventional controller thatallows adjustment of only a single operational parameter out of fearthat they may need to adjust a different operational parameter whileaway from a more full-featured controller.

In the embodiment shown, the display 126 is an LCD display arranged toconvey information to the user regarding selectable options, presentsettings, operating parameters and other information about the IPG 102or the pocket controller 104. In this example, the display 126 shows thepocket controller's battery status at 132, the IPG's battery status at134, the IPG's on or off status at 136, the currently selectedelectrical stimulation program at 138, and the amplitude setting of therunning electrical stimulation program at 140. Other types of displaysare also contemplated.

FIG. 4 shows a block diagram of components making up the pocketcontroller 104. It includes a user interface 150, a control module 152,a communication module 154, and a power storing controller 156. The userinterface 150 is comprised of the buttons 128 a, 128 b, 130 and thedisplay 126 described above with reference to FIG. 3A.

As can be seen, the user interface 150 is in communication with thecontrol module 152. The control module 152 comprises a processor 158,memory, an analog-digital converter 162, and a watch dog circuit 164.The processor 158 may include a microprocessor, a controller, a digitalsignal processor (DSP), an application specific integrated circuit(ASIC), a field programmable gate array (FPGA), discrete logiccircuitry, or the like. The processor 158 is configured to execute codeor instructions provided in the memory. Here, the memory is comprised offlash memory 166 and RAM memory 168. However, the memory may include anyvolatile or non-volatile media, such as a random access memory (RAM),read only memory (ROM), non-volatile RAM (NVRAM), electrically erasableprogrammable ROM (EEPROM), flash memory, and the like. In someembodiments, the memory stores sets of stimulation control parametersthat are available to be selected for delivery through the communicationmodule 154 to the IPG 102 for electrical stimulation therapy. The ADconverter 162 performs known functions of converting signals and the WD164 is arranged to time out when necessary, such as in an event wherethe software becomes stuck in a loop. In one embodiment, the controlmodule 152 comprises integrated circuits disposed on a PC board.

The communication module 154 comprises a medical implant communicationservice (MICS) RF transceiver 172 used to communicate with the IPG 102to communicate desired changes and to receive status updates from andrelating to the IPG 102, such as battery status and any errorinformation. As used herein, MICS refers to wireless communications in afrequency band ranging from about 402 MHz to about 405 MHz, which isdedicated for communications with implanted medical devices. In thisexample, the MICS RF transceiver 172 utilizes a loop antenna for thecommunications with the IPG 102. Other antennas, such as, for example,dipole, chip antennas, or other known in the art also may be used. Thecommunication module 154 also includes a wake up transmitter 174, anamplifier 176, and matching networks 178. The wake up transmitter 174operates on a high frequency and is configured to send a short signalburst to wake up the IPG 102 when it is in a power-saving mode. Once theIPG 102 is ready, a communications link can be established between theIPG 102 and pocket controller 104, and communications can then occurover the MICS transceiver 172 using a standard frequency for a medicaldevice transmission. The matching networks 178 tunes the antenna foroptimum transmission power for the frequency selected. The pocketcontroller 104 also includes a programming interface 182. This may beused during manufacturing to load an operating system and program thepocket controller 104.

The power storing controller 156 is configured to convert power torecharge one or more rechargeable batteries 180. The batteries 180provide power to operate the pocket controller 104 allowing it toreceive user inputs and transmit control signals to the IPG 102. Someembodiments use primary cell batteries instead of rechargeablebatteries. As indicated above, this pocket controller 104 is part of alarger system that contains the PPC 106 with a rich feature set forcontrolling the IPG 102 and includes an integrated battery charger usedto charge the IPG's battery. By providing both the pocket controller 104and the PPC 106, the patient can have a small unobtrusive device tocarry around as they go about their daily business and a larger morefull featured device which they can use in the comfort and privacy oftheir homes.

The pocket controller 104 is not only comfortable to carry in a pocket,but can also be attached to a key ring, lanyard, or other such carryingdevice for ease of daily use. Its functions are a subset of functionsfound on the PPC 106, and permit a user to power stimulation from theIPG on and off (i.e., the IPG 102 remains on, but stimulation is toggledbetween the on state when the IPG 102 is emitting electrical pulses andthe off state when the IPG 102 is not emitting electrical pulses butremains in the standby mode for additional communications from thepocket controller 104, the PPC 106, or both), select which electricalstimulation program to run, and globally adjust the amplitude ofelectrical pulses emitted in a series of electrical pulses emitted bythe IPG 102. By limiting the functions of the pocket controller to thosemost commonly used on a daily basis, the device becomes much lessintimidating to the patient, and allows it to be kept very small. Bykeeping the device small, such as about key fob size, it becomesunobtrusive and the patient is more comfortable with having and using animplanted device.

FIGS. 5A-5B show the PPC 106 in greater detail. FIG. 5A is a front viewof the PPC and FIG. 5B is a top view of FIG. 5A. The PPC 106 performsall the same operating functions as the pocket controller 104, butincludes additional operating functions making it a multi-functionfull-featured, advanced patient controller charger. In the embodimentshown, the PPC 106 provides a simple but rich feature set to the moreadvanced user, along with the charging functions.

The PPC 106 includes a controller-charger portion 200 and a coil portion202 connected by a flexible cable 204 and sharing components asdescribed below. The controller-charger portion 200 comprises an outerhousing 206 having an on-off switch 208 on its side, a plurality ofcontrol buttons 210, and a display 212, and an emergency off button (notshown, but disposed on a side of the housing 206 opposing the on-offswitch 208). In this embodiment, the control buttons 210 are icons onthe display 212, and the display is a full color, touch screen,graphical user interface. In addition, the controller-charger portion200 includes a home button 214 configured to return the displayed imagesto a home screen. The controller-charger portion 200 is larger than thepocket controller 104 and in one embodiment is sized with a heightgreater than about 3 inches, a width greater than about 2.5 inches, anda thickness greater than about 0.8 inch. In another embodiment, thecontroller-charger portion is sized with a width of about 3.1 inches, aheight of about 4.5 inches, and thickness of about 0.96 inches, althoughboth larger and smaller sizes are contemplated.

In this example, the control buttons 210 allow a user to select adesired feature for control or further display. Particularly, thecontrol buttons 210 enable functions of the PPC 106 that are the same asthose of the pocket controller 104 (stimulation on/off, programstimulation amplitude adjustment, and stimulation program selection)along with additional features including: charging IPG battery,individual pulse stimulation amplitude adjustment that adjusts anamplitude of an individual pulse relative to the amplitude of anadjacent pulse in a series of pulses emitted by the IPG 102, stimulationprogram frequency adjustment, individual pulse width adjustment,detailed IPG status, detailed PPC status, PPC setup/configuration, a PPCbattery status indicator, PPC to IPG communication status indicator, andother items and functions. The detailed IPG status may include, forexample, IPG serial number and IPG software revision level. Detailed PPCstatus may include, for example, date and time setting, brightnesscontrol, audio volume and mute control, and PPC serial number andsoftware revision level.

By having a pocket controller 104 that is limited to a plurality, suchas only three controls (stimulation on/off, program amplitude adjust,and stimulation program selection), for example, a user can quickly andeasily identify and select the features that are most commonly used.Features that are used less frequently, such as IPG recharge, areincluded on the full-featured PPC, but not the pocket controller 104.Features that are seldom accessed, or not accessed at all by some users,including individual pulse amplitude adjust, pulse width adjust,stimulation program frequency adjust, or serial number and softwarerevision information, are also not included on the limited-featurepocket controller, but are included on the PPC. This allows the pocketcontroller to be significantly smaller, with a very simple and easy touser interface, as compared to systems that need to support all of thesefeatures.

Referring to the example shown in FIG. 5A, the touch screen display 212is arranged to convey information to the user regarding selectableoptions, current settings, operating parameters and other informationabout the IPG 102 or the PPC 106. In this example, the display 212 showsa MICS communication indicator 220, the PPC's battery status at 222, theIPG's battery status at 224, the IPG's on or off status at 226, thecurrently selected electrical stimulation program at 228, and theamplitude setting of the active electrical stimulation program at 230.In addition, the display 212 shows the frequency 232, the pulse widthsetting 234, a selectable status icon for accessing detailed PPCinformation 236, a selectable status icon for accessing detailed IPGinformation 238, and a selectable icon for enabling IPG charging 240.Selecting any single icon may activate another menu within that selectedsubject area. The controller-charger portion 200 may include arechargeable battery whose charge status is shown by the PPC's batterystatus at 222.

The coil portion 202 is configured to wirelessly charge the batteries inthe IPG 102. In use, the coil portion 202 is applied against thepatient's skin or clothing externally so that energy can be inductivelytransmitted and stored in the IPG battery. As noted above, the coilportion 202 is connected with the integrated controller-charger portion200. Accordingly, the controller-charger portion 200 can simultaneouslydisplay the current status of the coil portion 204, the battery powerlevel of the IPG 102, as well as the battery power level of the PPC.Accordingly, controlling and charging can occur in a more simplistic,time-effective manner, where the patient can perform all IPG maintenancein a single sitting. In addition, since the most commonly used featuresof the PPC 106 are already functional on the pocket controller, the PPC106 may be left at home when the user does not desire to carry thelarger, more bulky PPC.

FIG. 6 shows a block diagram of the components making up the PPC 106. Itincludes a user interface 250, a control module 252, a communicationmodule 254, an IPG power charging module 256, and a power storing module258. The user interface 250 is comprised of the buttons 210 and thedisplay 212 described above. In this embodiment however, the userinterface 250 also includes one or more LEDs 266 signifying whether thePPC 106 is charging or powered on and a backlight 268 that illuminatesthe color display. In some embodiments, these LEDs may have colorssymbolizing the occurring function. An LED driver 270 and a speaker oramplifier 272 also form a part of the user interface 250.

As can be seen, the user interface 250 is in communication with thecontrol module 252. The control module 252 comprises a processor 276,memory 278, and a power management integrated circuit (PMIC)/real timeclock (RTC) 280. In the example shown, the control module 252 alsoincludes a Wi-Fi RF transceiver 282 that allows the PPC 106 to connectto a wireless network for data transfer. For example, it may permitdoctor-patient interaction via the internet, remote access to PPC logfiles, remote diagnostics, and other information transfer functions. ThePMIC 280 is configured to control the charging aspects of the PPC 106.The Wi-Fi transceiver 282 enables Wi-Fi data transfer for programmingthe PPC 106, and may permit wireless access to stored data and operatingparameters. Some embodiments also include a Bluetooth RF transceiver forcommunication with, for example, a Bluetooth enabled printer, akeyboard, etc.

In one embodiment, the control module 252 also includes an AD converterand a watch dog circuit as described above with reference to the controlmodule 252. Here, the memory 278 is comprised of flash memory and RAMmemory, but may be other memory as described above. In some embodiments,the processor 276 is an embedded processor running a WinCE operatingsystem (or any real time OS) with the graphics interface 250, and thememory 278 stores sets of stimulation control parameters that areavailable to be selected for delivery through the communication module254 to the IPG 102 for electrical stimulation therapy. In oneembodiment, the control module 252 comprises integrated circuitsdisposed on a PC board.

The communication module 254 comprises a MICS RF transceiver 290, a wakeup transmitter 292, an amplifier 294, and matching networks 296. Thecommunication module 254 may be similar to the communication module 154discussed above, and will not be further described here. The PPC 206also includes a programming interface 298 that may be used duringmanufacturing to load an operating system and program the PPC 206.

The power storing module 258 is configured to convert power to rechargeone or more rechargeable batteries 302. In this embodiment, thebatteries 302 are lithium-ion cells that provide power to operate thePPC 106 allowing it to receive user inputs, transmit control signals to,and charge the IPG 102. The power storing module 258 includes aconnector 304 for connecting to a power source, a power protectiondetection circuit 306 for protecting the PPC from power surges, andlinear power supplies 308 for assisting with the electric transfer tocharge the batteries 302. As can be seen, the control module 252 aidswith the charging and is configured to monitor and send the batterycharge level to the user interface 250 for display. The connector 304connects the PPC, directly or indirectly, to a power source (not shown)such as a conventional wall outlet for receiving electrical current. Insome embodiments, the connector 304 comprises a cradle.

The power charging module 256 communicates with the control module 252and is arranged to magnetically or inductively charge the IPG 102. Inthe embodiments shown, it is magnetically or inductively coupled to theIPG 102 to charge rechargeable batteries on the IPG 102. The chargingmodule 256 includes components in both the controller-charger portion200 and the coil portion 202 (FIGS. 5A-5B). It includes switch boostcircuitry 316, a load power monitor 318, an LSK demodulator 321, a ASKmodulator 322, a current mode transmitter 324, an ADC 326, and coils328. As can be seen, the control module 252 aids with the charging andis configured to monitor and send the IPG battery charge level to theuser interface 250 for display.

In this embodiment, the coils 328 are disposed in the coil portion 202and are configured to create magnetic or inductive coupling withcomponents in the IPG 102. Since the coil portion 202 is integrated withthe controller-charger portion 200, both operate from a single battery302. Accordingly, as can be seen by the circuitry, the battery 302powers the control module 252 and all its associated components. Inaddition, the battery 302 powers the power charging module 256 forrecharging the IPG 102.

Because the coil portion 202 is integrated with the controller-chargerportion 200, the control module 252 provides a single control interfaceand a single user interface for performing both functions of controllingthe IPG 102 and of charging the IPG 102. In addition, because thecontroller-charger portion 200 and the coil portion 202 are integrated,the controller-charger portion 200 simultaneously controls both thecurrent status of the charger, the battery power level of the IPG 102,as well as the battery power level of the PPC. Accordingly, controllingand charging can occur in a more simplistic, time-effective manner,where the patient can perform all IPG maintenance in a single sitting.In addition, since the most commonly used features of the PPC 106 arealready functional on the pocket controller, the PPC 106 may be left athome when the user does not desire to carry the larger, more bulky PPC.

FIG. 7 shows a block diagram of one example embodiment of a clinicianprogrammer (CP), for example the CP 22 shown in FIG. 2B. The CP 22includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the CP 22. With reference to FIG.7, the CP includes a processor 300. The processor 300 is a controllerfor controlling the CP 22 and, indirectly, the IPG 20 as discussedfurther below. In one construction, the processor 300 is an applicationsprocessor model i.MX515 available from Freescale Semiconductor. Morespecifically, the i.MX515 applications processor has internalinstruction and data cashes, multimedia capabilities, external memoryinterfacing, and interfacing flexibility. Further information regardingthe i.MX515 applications processor can be found in, for example, the“IMX510EC, Rev. 4” data sheet; dated August 2010; published by FreescaleSemiconductor at www.freescale.com, the content of the data sheet beingincorporated herein by reference. Of course, other processing units,such as other microprocessors, microcontrollers, digital signalprocessors, etc., can be used in place of the processor 300.

The CP 22 includes memory, which can be internal to the processor 300(e.g., memory 305), external to the processor 300 (e.g., memory 310), ora combination of both. Exemplary memory include a read-only memory(“ROM”), a random access memory (“RAM”), an electrically erasableprogrammable read-only memory (“EEPROM”), a flash memory, a hard disk,or another suitable magnetic, optical, physical, or electronic memorydevice. The processor 300 executes software that is capable of beingstored in the RAM (e.g., during execution), the ROM (e.g., on agenerally permanent basis), or another non-transitory computer readablemedium such as another memory or a disc. The CP 22 also includesinput/output (“I/O”) systems that include routines for transferringinformation between components within the processor 300 and othercomponents of the CP 22 or external to the CP 22.

Software included in the implementation of the CP 22 is stored in thememory 305 of the processor 300, memory 310 (e.g., RAM or ROM), orexternal to the CP 22. The software includes, for example, firmware, oneor more applications, program data, one or more program modules, andother executable instructions. The processor 300 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for the CP22. For example, the processor 300 is configured to execute instructionsretrieved from the memory 140 for establishing a protocol to control theIPG 20.

One memory shown in FIG. 7 is memory 310, which can be a double datarate (DDR2) synchronous dynamic random access memory (SDRAM) for storingdata relating to and captured during the operation of the CP 22. Inaddition, a secure digital (SD) multimedia card (MMC) can be coupled tothe CP for transferring data from the CP to the memory card via slot315. Of course, other types of data storage devices can be used in placeof the data storage devices shown in FIG. 7.

The CP 22 includes multiple bi-directional radio communicationcapabilities. Specific wireless portions included with the CP 22 are aMedical Implant Communication Service (MICS) bi-direction radiocommunication portion 320, a Wi-Fi bi-direction radio communicationportion 325, and a Bluetooth bi-direction radio communication portion330. The MICS portion 320 includes a MICS communication interface, anantenna switch, and a related antenna, all of which allows wirelesscommunication using the MICS specification. The Wi-Fi portion 325 andBluetooth portion 330 include a Wi-Fi communication interface, aBluetooth communication interface, an antenna switch, and a relatedantenna all of which allows wireless communication following the Wi-FiAlliance standard and Bluetooth Special Interest Group standard. Ofcourse, other wireless local area network (WLAN) standards and wirelesspersonal area networks (WPAN) standards can be used with the CP 22.

The CP 22 includes three hard buttons: a “home” button 335 for returningthe CP to a home screen for the device, a “quick off” button 340 forquickly deactivating stimulation IPG, and a “reset” button 345 forrebooting the CP 22. The CP 22 also includes an “ON/OFF” switch 350,which is part of the power generation and management block (discussedbelow).

The CP 22 includes multiple communication portions for wiredcommunication. Exemplary circuitry and ports for receiving a wiredconnector include a portion and related port for supporting universalserial bus (USB) connectivity 355, including a Type-A port and a Micro-Bport; a portion and related port for supporting Joint Test Action Group(JTAG) connectivity 360, and a portion and related port for supportinguniversal asynchronous receiver/transmitter (UART) connectivity 365. Ofcourse, other wired communication standards and connectivity can be usedwith or in place of the types shown in FIG. 7.

Another device connectable to the CP 22, and therefore supported by theCP 22, is an external display. The connection to the external displaycan be made via a micro High-Definition Multimedia Interface (HDMI) 370,which provides a compact audio/video interface for transmittinguncompressed digital data to the external display. The use of the HDMIconnection 370 allows the CP 22 to transmit video (and audio)communication to an external display. This may be beneficial insituations where others (e.g., the surgeon) may want to view theinformation being viewed by the healthcare professional. The surgeontypically has no visual access to the CP 22 in the operating room unlessan external screen is provided. The HDMI connection 370 allows thesurgeon to view information from the CP 22, thereby allowing greatercommunication between the clinician and the surgeon. For a specificexample, the HDMI connection 370 can broadcast a high definitiontelevision signal that allows the surgeon to view the same informationthat is shown on the LCD (discussed below) of the CP 22.

The CP 22 includes a touch screen I/O device 375 for providing a userinterface with the clinician. The touch screen display 375 can be aliquid crystal display (LCD) having a resistive, capacitive, or similartouch-screen technology. It is envisioned that multitouch capabilitiescan be used with the touch screen display 375 depending on the type oftechnology used.

The CP 22 includes a camera 380 allowing the device to take pictures orvideo. The resulting image files can be used to document a procedure oran aspect of the procedure. For example, the camera 380 can be used totake pictures of barcodes associated with the IPG 20 or the leads 120,or documenting an aspect of the procedure, such as the positioning ofthe leads. Similarly, it is envisioned that the CP 22 can communicatewith a fluoroscope or similar device to provide further documentation ofthe procedure. Other devices can be coupled to the CP 22 to providefurther information, such as scanners or RFID detection. Similarly, theCP 22 includes an audio portion 385 having an audio codec circuit, audiopower amplifier, and related speaker for providing audio communicationto the user, such as the clinician or the surgeon.

The CP 22 further includes a power generation and management block 390.The power generation and management block 390 has a power source (e.g.,a lithium-ion battery) and a power supply for providing multiple powervoltages to the processor, LCD touch screen, and peripherals.

FIG. 8 shows a block diagram of an example embodiment of an IPG, forexample an embodiment of the IPG 20 shown in FIG. 2B. The IPG 20includes a printed circuit board (“PCB”) that is populated with aplurality of electrical and electronic components that provide power,operational control, and protection to the IPG 20. With reference toFIG. 8, the IPG 20 includes a communication portion 400 having atransceiver 405, a matching network 410, and antenna 412. Thecommunication portion 400 receives power from a power ASIC (discussedbelow), and communicates information to/from the microcontroller 415 anda device (e.g., the CP 22) external to the IPG 20. For example, the IPG20 can provide bi-direction radio communication capabilities, includingMedical Implant Communication Service (MICS) bi-direction radiocommunication following the MICS specification.

The IPG 20, as previously discussed, provides stimuli to electrodes 150of an implanted medical electrical lead 110. As shown in FIG. 8, Nelectrodes 150 are connected to the IPG 20. In addition, the enclosureor housing 420 of the IPG 20 can act as an electrode. The stimuli areprovided by a stimulation portion 425 in response to commands from themicrocontroller 415. The stimulation portion 425 includes a stimulationapplication specific integrated circuit (ASIC) 430 and circuitryincluding blocking capacitors and an over-voltage protection circuit. Asis well known, an ASIC is an integrated circuit customized for aparticular use, rather than for general purpose use. ASICs often includeprocessors, memory blocks including ROM, RAM, EEPROM, Flash, etc. Thestimulation ASIC 430 can include a processor, memory, and firmware forstoring preset pulses and protocols that can be selected via themicrocontroller 415. The providing of the pulses to the electrodes 150is controlled through the use of a waveform generator and amplitudemultiplier of the stimulation ASIC 430, and the blocking capacitors andovervoltage protection circuitry of the stimulation portion 425, as isknown in the art. The stimulation portion 425 of the IPG 20 receivespower from the power ASIC (discussed below). The stimulation ASIC 430also provides signals to the microcontroller 415. More specifically, thestimulation ASIC 430 can provide impedance values for the channelsassociated with the electrodes 150, and also communicate calibrationinformation with the microcontroller 415 during calibration of the IPG20.

The IPG 20 also includes a power supply portion 440. The power supplyportion includes a rechargeable battery 445, fuse 450, power ASIC 455,recharge coil 460, rectifier 463 and data modulation circuit 465. Therechargeable battery 445 provides a power source for the power supplyportion 440. The recharge coil 460 receives a wireless signal from thePPC 135. The wireless signal includes an energy that is converted andconditioned to a power signal by the rectifier 463. The power signal isprovided to the rechargeable battery 445 via the power ASIC 455. Thepower ASIC 455 manages the power for the IPG 20. The power ASIC 455provides one or more voltages to the other electrical and electroniccircuits of the IPG 155. The data modulation circuit 465 controls thecharging process.

The IPG also includes a sensor section 470 that includes a thermistor475, an accelerometer 478, and a magnetic sensor 480. The thermistor 475detects temperature of the IPG. The accelerometer detects motion ormovement of the IPG, and the magnetic sensor 480 provides a “hard”switch upon sensing a magnet for a defined period. The signal from themagnetic sensor 480 can provide an override for the IPG 20 if a fault isoccurring with the IPG 20 and is not responding to other controllers.The magnetic sensor 480 can also be used to turn on and off stimulation.

The IPG 20 is shown in FIG. 8 as having a microcontroller 415. Generallyspeaking, the microcontroller 415 is a controller for controlling theIPG 20. The microcontroller 415 includes a suitable programmable portion481 (e.g., a microprocessor or a digital signal processor), a memory482, and a bus or other communication lines. An exemplarymicrocontroller capable of being used with the IPG is a model MSP430ultra-low power, mixed signal processor by Texas Instruments. Morespecifically, the MSP430 mixed signal processor has internal RAM andflash memories, an internal clock, and peripheral interfacecapabilities. Further information regarding the MSP 430 mixed signalprocessor can be found in, for example, the “MSP430G2x32, MSP430G2x02MIXED SIGNAL MICROCONTROLLER” data sheet; dated December 2010, publishedby Texas Instruments at www.ti.com; the content of the data sheet beingincorporated herein by reference.

The IPG 20 includes memory, which can be internal to the control device(such as memory 482), external to the control device (such as serialmemory 495), or a combination of both. Exemplary memory include aread-only memory (“ROM”), a random access memory (“RAM”), anelectrically erasable programmable read-only memory (“EEPROM”), a flashmemory, a hard disk, or another suitable magnetic, optical, physical, orelectronic memory device. The programmable portion 481 executes softwarethat is capable of being stored in the RAM (e.g., during execution), theROM (e.g., on a generally permanent basis), or another non-transitorycomputer readable medium such as another memory or a disc.

Software included in the implementation of the IPG 20 is stored in thememory 482. The software includes, for example, firmware, one or moreapplications, program data, one or more program modules, and otherexecutable instructions. The programmable portion 481 is configured toretrieve from memory and execute, among other things, instructionsrelated to the control processes and methods described below for the IPG20. For example, the programmable portion 481 is configured to executeinstructions retrieved from the memory 482 for sweeping the electrodesin response to a signal from the CP 22.

The PCB also includes a plurality of additional passive and activecomponents such as resistors, capacitors, inductors, integratedcircuits, and amplifiers. These components are arranged and connected toprovide a plurality of electrical functions to the PCB including, amongother things, filtering, signal conditioning, or voltage regulation, asis commonly known.

FIG. 9 is a block diagram of an exemplary handheld patient feedbackdevice or patient feedback tool (hereinafter interchangeably referred toas PFD or PFT) 500 for use in a neurostimulation system, and FIGS. 10Aand 10B are diagrammatic illustrations of the PFT 500 according tovarious example embodiments. With reference to FIGS. 9 and 10A-10B, thePFT 500 includes a housing 502 which may have one or more of a sensor, acontroller, and/or a communication port connected thereto. Theconstruction of the PFT 500 shown in FIG. 9 includes two inputs 504 and505 in communication with the housing 502 of the device 500 and oneinput 510 internal to the housing 502. One of the external inputs 504 isa binary ON/OFF switch, for example activated by the patient's thumb, toallow the patient to immediately deactivate stimulation. Input 504 maybe coupled to the controller 525 via electrostatic discharge (ESD)protection and/or debouncing circuits. The second input 505 includes aforce sensor sensing the pressure or force exerted by the patient'shand. Input/sensor 505 may be coupled to the controller 525 via ESDprotection, signal conditioning, and/or signal amplification circuits.The sensed parameter can be either isotonic (constant force, measuringthe distance traversed) or isometric (measured force, proportional topressure applied by patient). The resulting signal from the sensor 505is analog and, therefore, after the signal is conditioned and/oramplified, it can be passed to microcontroller 525 via ananalog-to-digital converter.

The internal input 510 for the PFT 500 may be a motion sensor. Thesensor 510, upon detecting motion, initiates activation of the PFT 500.The device 500 stays active until movement is not detected by the sensor510 for a time period, which in various constructions may be between onesecond and five minutes. Power is provided by an internal battery 520that can be replaceable and/or rechargeable, which in variousconstructions has an approximately three hour life under continuous use.As discussed below, a motion sensor such as sensor 510 can also be usedto obtain feedback from the patient regarding paresthesia.

The processing of the inputs from the sensors 504 and 505 takes place ina controller, such as a microcontroller 525. An exemplarymicrocontroller capable of being used with the invention ismicrocontroller 525, which includes a suitable programmable portion 530(e.g., a microprocessor or a digital signal processor), a memory 535,and a bus 540 or other communication lines. Output data of themicrocontroller 525 is sent via a Bluetooth bi-direction radiocommunication port 545 to the CP (clinician programmer). The Bluetoothportion 545 includes a Bluetooth communication interface, an antennaswitch, and a related antenna, all of which allows wirelesscommunication following the Bluetooth Special Interest Group standard.Other forms of wired and wireless communication between the PFT 500 andother components of the system including the CP are also possible. Otheroutputs may include indicators (such as light-emitting diodes) forcommunicating stimulation activity 550, sensor activation 555, devicepower 560, and battery status 565.

The housing 502 of the PFT 500 may be cylindrical in shape, and in oneparticular construction the cylinder is approximately 35 mm in diameterand 80 mm in length. In other constructions the cylinder is larger orsmaller in diameter and/or length, for example in order to accommodatehands of varying sizes. In various constructions the diameter can rangefrom 20 to 50 mm and the length from 30 to 120 mm, although other sizesabove and below these ranges are also possible.

Furthermore, the shape of the PFT 500 can be other than a circularcross-section, for example oval, square, hexagonal, or other shape.Still further, the cross-section of the PFT 500 can vary along itslength, for example being cylindrical in some portions and oval, square,hexagonal or other shape(s) in other portions. In yet otherconstructions, the PFT 500 has a spherical, toroid, or other shape.

The housing 502 may be made from a resilient material such as rubber orplastic with one or more sensor 505 coupled to or supported by thehousing 502. The manner in which the sensor 505 is coupled to thehousing 502 depends on the type of sensor that is employed, as discussedbelow. Thus, when the patient applies a force to the housing 502, thesensor 505 generates a signal that generally is proportional to thedegree of force applied. Although the discussion herein mentions thepatient using his or her hand to generate force to squeeze the housing502 of the PFT 500, in various constructions the patient may instead useother body parts, such as the mouth or foot, to generate force. Moregenerally, the patient can generate feedback by a physical action,usually a force applied by the hand or other body part, but the physicalaction can include other movements, such as movement of the patient'seyes, head, or hands, to generate a feedback signal.

After the signal is generated, it is transmitted from the sensor 505 tothe controller 525. The controller 525 processes the signal and, basedon one or more such signals from the sensor 505, the controller 525generates another signal that is to be transmitted to the CP. Thecontroller 525 sends the signal to be transmitted to the communicationport 545 of the PFT 500 from which it is then transmitted to the CP orother external device. As discussed further below, the signal can betransmitted from the communication port 545 to the CP using variouswired or wireless methods of communication.

In various constructions, an isotonic force sensor may include a sensorthat measures the distance traveled by the sensor with relativelyconstant force applied by the patient. Isotonic force sensors mayinclude a trigger 570 (See FIG. 10A) or other lever mechanism coupled toa wiper 572 that moves along a rheostat 574 or across a series ofdetectors. Exemplary detectors include electrical contacts or opticaldetectors, such as photodiodes. In other constructions, an isometricforce sensor may include a strain gauge, a piezoelectric device, or apressure sensor, each of which measures force that is proportional tothe pressure applied to the PFT 500 by the patient, generally with onlya small amount of travel or shape change to the sensor.

Both the isotonic and isometric sensors generate an electrical signalthat is proportional to the force that is applied to the sensor. Anisometric force sensor may be incorporated into a relatively stiffobject such that only slight deformation of the object is needed toregister a change in force. In still other constructions, the forcesensor may include a combination of elements, such as a trigger or otherlever that experiences increasing resistance or pressure as the traveldistance increases. For example, increasing resistance or pressure canbe created by attaching a relatively stiff spring to the lever or wipermechanism to increase resistance as the lever or wiper is moved.

In some constructions (e.g. as shown in FIG. 10B), the PFT 500 includesa feedback mechanism 580 that indicates to the patient the amount offorce that is detected by the force sensor 505. The feedback mechanism580 may include one or more of a visual, audible, or tactile feedbackmechanism that is used to indicate to the patient the degree to whichthe sensor 505 has been activated, e.g., how much force has been appliedor how much the lever or wiper mechanism has traveled. The feedbackmechanism gives the patient a sense of whether their activation of thesensor 505 is being detected at what the patient feels is the correctlevel and to give the patient a means to make their activation of thesensor 505 more consistent.

Visual feedback mechanisms 580 can include a series of lights (e.g.LEDs) or a digital readout (e.g. a numerical display); audible feedbackcan include sounds that vary in amplitude (volume) and/or tone; andtactile feedback mechanisms can include vibration of the PFT 500 and/oraltering the shape of the surface of the PFT 500 (e.g. raising of one ormore structures such as dots to form Braille-type patterns) in alocation that is capable of contacting the patient's skin. Using acombination of feedback modalities will benefit patients who havesensory impairments, including, e.g., impaired hearing and/or sight.

The feedback can include a semi-quantitative indication of the patient'sresponse, e.g. including a variety of (e.g. 1-5 or 1-10) intensitylevels to indicate a relative degree of force applied by the patient.The patient will then be able to see, hear, and/or feel the level offorce that is sensed by the sensor 505 of the PFT 500, to help thepatient confirm that their response to the stimulus was received, aswell as the degree of response that was registered. The correlationbetween the level of force applied and the output of the feedbackmechanism 580 can be calibrated separately for each patient during aninitial calibration session.

To facilitate gripping of the PFT 500, the housing 502, in certainconstructions, may be covered with one or more surfaces, textures, ormaterials to improve grip, such as grooves, stipples, indentations,rubber, or plastic, and may include a wrist strap 582 to keep the PFT500 from falling if it is dropped by the patient.

The PFT 500, in some constructions, may also include a connectionfeedback mechanism, particularly where the PFT 500 is in wirelesscommunication with the CP. The connection feedback mechanism can includeone or more of a visual, audible, or tactile mechanism to inform thepatient and/or medical personnel of whether the PFT 500 is maintaining aconnection with the CP, the strength of the connection, and/or if theconnection has been lost. For example, the PFT 500 may emit a signal(e.g., light, sound, and/or tactile) at regular (e.g., one minute)intervals to confirm that communication is still maintained.

Conversely, the PFT 500 may emit such a signal only if communication islost. In some constructions, the PFT 500 may tolerate brief intervals inwhich the signal is lost (e.g., a predetermined time, generally between0.1-100 sec) before the patient is warned of a possible lost connection.In various constructions, the controller 525 of the PFT 500 includesmemory that permits buffering of a limited amount of data, which can beused to accumulate data prior to sending to the CP and which can holddata during brief intervals in which the connection is lost. In variousconstructions, if communication between the PFT 500 and the CP is lostfor more than a predetermined interval of time, then the CP stopsstimulation of electrodes until a connection with the PFT 500 isreestablished.

Thus, according to various constructions, the PFT 500 may include one ormore of: a sound generating mechanism 584 (e.g., a speaker); a tactilemechanism 586 such as a vibration device and/or a mechanism for creatinga raised pattern; a digital numerical readout 588 (e.g., LED or LCDdisplay); and one or more indicator lights 590 (e.g., a series of LEDs);which may be employed to provide feedback to the patient regarding theforce being applied and/or communication status.

Various types of sensing mechanisms can be used for the sensor 505,which would depend in part on the type of housing 502 that is used withthe PFT 500. For example, if the housing 502 is a sealed, flexiblecompartment (e.g., a ball or other object filled with gel, air, orliquid) a piezoelectric-based pressure sensing mechanism can be used asthe sensor 505 in order to measure changes in pressure when the patientsqueezes or relaxes his/her grip on the PFT 500. Alternatively, arheostat 574 or other linear sensing mechanism can be used with a pistolgrip style PFT 500 design (FIG. 10A), where a trigger 570 is coupled toa wiper 572 that moves across the rheostat 574 or other linear sensor.

FIGS. 11A-11C illustrate other embodiments of the PFT for receivingpatient feedback. More specifically, FIG. 11A shows a mouth-piece 620that is inserted into the mouth of the patient. The user providesfeedback by biting the mouthpiece. FIG. 11B shows an optical sensor 630(such as a camera and related image processing software) that detectsvisual cues from a patient. An example visual cue may be the blinking ofthe patient's eyes. FIG. 11C shows a foot pedal 640 that receives inputthrough the patient's manipulation of a switch and/or sensor with hisfoot. In some constructions, the PFT 500 includes one or moreaccelerometers (such as the motion sensor 510), and the patient providesfeedback by moving the PFT 500 in various distinct patterns that arerecognized by the controller 525 of the PFT 500 or by the CP.

It is also envisioned that the patient may provide feedback directly tothe CP. In various constructions, the patient is trained to use theparticular feedback device (e.g. the PFT 500 or the CP as applicable) inorder to properly inform the CP of the patient's reaction to stimuli asthey are applied to the IPG in the patient. In particular constructions,the CP is programmed to learn the patient's response times and/or themagnitude of the patient's responses in order to obtain a profile of thepatient's reaction to various stimuli, as discussed above.

Referring now to FIG. 12, a simplified block diagram of a medicalinfrastructure 800 (which may also be considered a medical system) isillustrated according to various aspects of the present disclosure. Themedical infrastructure 800 includes a plurality of medical devices 810.These medical devices 810 may each be a programmable medical device (orparts thereof) that can deliver a medical therapy to a patient. In someembodiments, the medical devices 810 may include a device of theneurostimulator system discussed above. For example, the medical devices810 may be a pulse generator (e.g., the IPG discussed above), animplantable lead, a charger, or portions thereof. It is understood thateach of the medical devices 810 may be a different type of medicaldevice. In other words, the medical devices 810 need not be the sametype of medical device.

The medical infrastructure 800 also includes a plurality of electronicprogrammers 820. For sake of illustration, one of these electronicprogrammers 820A is illustrated in more detail and discussed in detailbelow. Nevertheless, it is understood that each of the electronicprogrammers 820 may be implemented similar to the electronic programmer820A.

In some embodiments, the electronic programmer 820A may be a clinicianprogrammer, for example the clinician programmer discussed above withreference to FIGS. 2B and 7. In other embodiments, the electronicprogrammer 820A may be a patient programmer discussed above withreference to FIGS. 2B-6. In further embodiments, it is understood thatthe electronic programmer may be a tablet computer. In any case, theelectronic programmer 820A is configured to program the stimulationparameters of the medical devices 810 so that a desired medical therapycan be delivered to a patient.

The electronic programmer 820A contains a communications component 830that is configured to conduct electronic communications with externaldevices. For example, the communications device 830 may include atransceiver. The transceiver contains various electronic circuitrycomponents configured to conduct telecommunications with one or moreexternal devices. The electronic circuitry components allow thetransceiver to conduct telecommunications in one or more of the wired orwireless telecommunications protocols, including communicationsprotocols such as IEEE 802.11 (Wi-Fi), IEEE 802.15 (Bluetooth), GSM,CDMA, LTE, WIMAX, DLNA, HDMI, Medical Implant Communication Service(MICS), etc. In some embodiments, the transceiver includes antennas,filters, switches, various kinds of amplifiers such as low-noiseamplifiers or power amplifiers, digital-to-analog (DAC) converters,analog-to-digital (ADC) converters, mixers, multiplexers anddemultiplexers, oscillators, and/or phase-locked loops (PLLs). Some ofthese electronic circuitry components may be integrated into a singlediscrete device or an integrated circuit (IC) chip.

The electronic programmer 820A contains a touchscreen component 840. Thetouchscreen component 840 may display a touch-sensitive graphical userinterface that is responsive to gesture-based user interactions. Thetouch-sensitive graphical user interface may detect a touch or amovement of a user's finger(s) on the touchscreen and interpret theseuser actions accordingly to perform appropriate tasks. The graphicaluser interface may also utilize a virtual keyboard to receive userinput. In some embodiments, the touch-sensitive screen may be acapacitive touchscreen. In other embodiments, the touch-sensitive screenmay be a resistive touchscreen.

It is understood that the electronic programmer 820A may optionallyinclude additional user input/output components that work in conjunctionwith the touchscreen component 840 to carry out communications with auser. For example, these additional user input/output components mayinclude physical and/or virtual buttons (such as power and volumebuttons) on or off the touch-sensitive screen, physical and/or virtualkeyboards, mouse, track balls, speakers, microphones, light-sensors,light-emitting diodes (LEDs), communications ports (such as USB or HDMIports), joy-sticks, etc.

The electronic programmer 820A contains an imaging component 850. Theimaging component 850 is configured to capture an image of a targetdevice via a scan. For example, the imaging component 850 may be acamera in some embodiments. The camera may be integrated into theelectronic programmer 820A. The camera can be used to take a picture ofa medical device, or scan a visual code of the medical device, forexample its barcode or Quick Response (QR) code.

The electronic programmer contains a memory storage component 860. Thememory storage component 860 may include system memory, (e.g., RAM),static storage (e.g., ROM), or a disk drive (e.g., magnetic or optical),or any other suitable types of computer readable storage media. Forexample, some common types of computer readable media may include floppydisk, flexible disk, hard disk, magnetic tape, any other magneticmedium, CD-ROM, any other optical medium, RAM, PROM, EPROM, FLASH-EPROM,any other memory chip or cartridge, or any other medium from which acomputer is adapted to read. The computer readable medium may include,but is not limited to, non-volatile media and volatile media. Thecomputer readable medium is tangible, concrete, and non-transitory.Logic (for example in the form of computer software code or computerinstructions) may be encoded in such computer readable medium. In someembodiments, the memory storage component 860 (or a portion thereof) maybe configured as a local database capable of storing electronic recordsof medical devices and/or their associated patients.

The electronic programmer contains a processor component 870. Theprocessor component 870 may include a central processing unit (CPU), agraphics processing unit (GPU) a micro-controller, a digital signalprocessor (DSP), or another suitable electronic processor capable ofhandling and executing instructions. In various embodiments, theprocessor component 870 may be implemented using various digital circuitblocks (including logic gates such as AND, OR, NAND, NOR, XOR gates,etc.) along with certain software code. In some embodiments, theprocessor component 870 may execute one or more sequences computerinstructions contained in the memory storage component 860 to performcertain tasks.

It is understood that hard-wired circuitry may be used in place of (orin combination with) software instructions to implement various aspectsof the present disclosure. Where applicable, various embodimentsprovided by the present disclosure may be implemented using hardware,software, or combinations of hardware and software. Also, whereapplicable, the various hardware components and/or software componentsset forth herein may be combined into composite components comprisingsoftware, hardware, and/or both without departing from the spirit of thepresent disclosure. Where applicable, the various hardware componentsand/or software components set forth herein may be separated intosub-components comprising software, hardware, or both without departingfrom the scope of the present disclosure. In addition, where applicable,it is contemplated that software components may be implemented ashardware components and vice-versa.

It is also understood that the electronic programmer 820A is notnecessarily limited to the components 830-870 discussed above, but itmay further include additional components that are used to carry out theprogramming tasks. These additional components are not discussed hereinfor reasons of simplicity. It is also understood that the medicalinfrastructure 800 may include a plurality of electronic programmerssimilar to the electronic programmer 820A discussed herein, but they arenot illustrated in FIG. 12 for reasons of simplicity.

The medical infrastructure 800 also includes an institutional computersystem 890. The institutional computer system 890 is coupled to theelectronic programmer 820A. In some embodiments, the institutionalcomputer system 890 is a computer system of a healthcare institution,for example a hospital. The institutional computer system 890 mayinclude one or more computer servers and/or client terminals that mayeach include the necessary computer hardware and software for conductingelectronic communications and performing programmed tasks. In variousembodiments, the institutional computer system 890 may includecommunications devices (e.g., transceivers), user input/output devices,memory storage devices, and computer processor devices that may sharesimilar properties with the various components 830-870 of the electronicprogrammer 820A discussed above. For example, the institutional computersystem 890 may include computer servers that are capable ofelectronically communicating with the electronic programmer 820A throughthe MICS protocol or another suitable networking protocol.

The medical infrastructure 800 includes a database 900. In variousembodiments, the database 900 is a remote database—that is, locatedremotely to the institutional computer system 890 and/or the electronicprogrammer 820A. The database 900 is electronically or communicatively(for example through the Internet) coupled to the institutional computersystem 890 and/or the electronic programmer. In some embodiments, thedatabase 900, the institutional computer system 890, and the electronicprogrammer 820A are parts of a cloud-based architecture. In that regard,the database 900 may include cloud-based resources such as mass storagecomputer servers with adequate memory resources to handle requests froma variety of clients. The institutional computer system 890 and theelectronic programmer 820A (or their respective users) may both beconsidered clients of the database 900. In certain embodiments, thefunctionality between the cloud-based resources and its clients may bedivided up in any appropriate manner. For example, the electronicprogrammer 820A may perform basic input/output interactions with a user,but a majority of the processing and caching may be performed by thecloud-based resources in the database 900. However, other divisions ofresponsibility are also possible in various embodiments.

According to the various aspects of the present disclosure, varioustypes of data may be uploaded from the electronic programmer 820A to thedatabase 900. The data saved in the database 900 may thereafter bedownloaded by any of the other electronic programmers 820B-820Ncommunicatively coupled to it, assuming the user of these programmershas the right login permissions.

The database 900 may also include a manufacturer's database in someembodiments. It may be configured to manage an electronic medical deviceinventory, monitor manufacturing of medical devices, control shipping ofmedical devices, and communicate with existing or potential buyers (suchas a healthcare institution). For example, communication with the buyermay include buying and usage history of medical devices and creation ofpurchase orders. A message can be automatically generated when a client(for example a hospital) is projected to run out of equipment, based onthe medical device usage trend analysis done by the database. Accordingto various aspects of the present disclosure, the database 900 is ableto provide these functionalities at least in part via communication withthe electronic programmer 820A and in response to the data sent by theelectronic programmer 820A. These functionalities of the database 900and its communications with the electronic programmer 820A will bediscussed in greater detail later.

The medical infrastructure 800 further includes a manufacturer computersystem 910. The manufacturer computer system 910 is also electronicallyor communicatively (for example through the Internet) coupled to thedatabase 900. Hence, the manufacturer computer system 910 may also beconsidered a part of the cloud architecture. The computer system 910 isa computer system of medical device manufacturer, for example amanufacturer of the medical devices 810 and/or the electronic programmer820A.

In various embodiments, the manufacturer computer system 910 may includeone or more computer servers and/or client terminals that each includesthe necessary computer hardware and software for conducting electroniccommunications and performing programmed tasks. In various embodiments,the manufacturer computer system 910 may include communications devices(e.g., transceivers), user input/output devices, memory storage devices,and computer processor devices that may share similar properties withthe various components 830-870 of the electronic programmer 820Adiscussed above. Since both the manufacturer computer system 910 and theelectronic programmer 820A are coupled to the database 900, themanufacturer computer system 910 and the electronic programmer 820A canconduct electronic communication with each other.

After an implantable lead (e.g., lead 10 discussed above with referenceto FIGS. 2A-2B) has been placed inside the patient, an electronicprogrammer (e.g., the clinician programmer 22 discussed above withreference to FIG. 7) may be used to program a pulse generator (e.g., IPG20 discussed above with reference to FIG. 8) to deliver electricalstimulation to the patient through the lead. For example, referring toFIGS. 13-14, the electronic programmer may provide a graphical userinterface 1100 for programming the stimulation therapy and for recordingthe patient's responses to the stimulation therapy. In FIG. 13, thegraphical user interface 1100 provides a menu 1500 that lists somecommon motor and sensory responses (collectively referred to as patientphysiological responses) the patient may exhibit in response to thestimulation. The motor responses may include foot, heel, leg, bellows,great toe, bottom foot, and other (e.g., the user can input a customresponse). The sensory responses may include genitals, perineum,tailbone, rectal, low extremity, butt cheek, and other (e.g., a customresponse).

In addition to the responses being observed by the healthcareprofessional, a patient feedback mechanism 1450 (e.g., an embodiment ofthe patient feedback devices discussed above with reference to FIGS.10A-10B and 11A-11C) may be used by the patient to communicate feedbackof the stimulation to the healthcare professional. When appropriate, thehealthcare professional may select one or more of these responses andpress the “submit” button to record the particular manner the patienthas responded to a given set of stimulation parameters and stimulationlocation. In another embodiment, the responses from the patient arerecorded using an automatic closed-loop system using evoked potentialsensors, for example as discussed in more detail in U.S. patentapplication Ser. No. 15/043,794, filed Feb. 15, 2016, the contents ofwhich are hereby incorporated by reference in its entirety.

Still referring to FIGS. 13-14, the graphical user interface 1100 alsodisplays a plurality of selectable buttons 1600-1620 to define thepatient's current sedation state. As non-limiting examples, the button1600 indicates that the patient is awake, another button 1610 indicatesthat the patient is sedated, and another button 1620 indicates that thepatient is under general anesthesia. Each patient sedation state mayhave its own corresponding patient responses. In other words, thepatient responses (and its associated stimulation parameters) may berecorded for each patient sedation state 1600/1610/1620. One of thereasons the sedation states are recorded in conjunction with patientresponses is to determine whether the therapy has changed over time. Thephysician may compare current responses with those from the ones storedin the electronic programmer.

Referring to FIG. 14, the graphical user interface 1100 displays avirtual connection between a percutaneous lead 1140 with an externalpulse generator (EPG) 1040 via a trial connector 1030. The graphicaluser interface 1100 in FIG. 14 also displays a plurality of selectablevirtual contacts 1650 on the implantable percutaneous lead 1140. Thecontacts 1650 on the lead 1140 are separate and independent from oneanother. For example, the contacts 1650 are not shorted together, andeach contact 1650 may be programmed with a different set of stimulationparameters like stimulation amplitude, frequency, pulse width, etc.

For each of these selected sedation states 1600/1610/1620, thehealthcare professional may select one or more contacts 1650 and recordthe patient responses (e.g., bellows or butt cheek) exhibited inassociation with that specific contact being activated to deliver thestimulation. In other words, each contact 1650 may have its owncorresponding recorded patient physiological response, a set ofstimulation parameters that resulted in the patient physiologicalresponse, and the patient's sedation state.

According to the various aspects of the present disclosure, the timingor chronological sequence of these responses may be an indication of howwell the lead has been placed. In more detail, suppose that a healthcareprofessional uses the electronic programmer to send instructions to theIPG to ramp up a stimulation parameter. The ramped up stimulationparameter is stimulation current amplitude in the illustratedembodiment, but it may be other stimulation parameters such asstimulation pulse width or stimulation voltage amplitude in alternativeembodiments. As the stimulation current amplitude is being ramped up bypredetermined step sizes (e.g., 0.05 or 0.1 mA each step), the patientmay exhibit the various physiological responses discussed above withreference to FIGS. 13-14. The following three responses are ofparticular interest for the purposes of the present disclosure: the analsphincter contraction response (also referred to as an anal wink), thebellows response, and the toes response. The anal sphincter contractionincludes an involuntary contraction of the anal sphincter. The bellowsresponse includes an involuntary contraction of the muscles near thepelvic floor. The toes response includes an involuntary plantar flexionof the big toe.

If the stimulation lead is well-placed, the patient should exhibit theanal sphincter contraction response before the bellows response, and thebellows response before the toes response, as the stimulation currentamplitude is being ramped up. In other words, a desired chronologicalsequence of these physiological responses should be

-   -   1. The anal sphincter contraction response;    -   2. The bellows response;    -   3. The toes response.        Anatomically, the efficacy of the sacral nerve stimulation is        dependent on the electrodes of the implanted lead being able to        reach the desired nerve fibers in the sacral nerve area.        However, based on existing tools and technology, it is difficult        to determine whether the lead has been placed sufficiently well        for the electrodes to reach the target nerve fibers. The        inventors of the present disclosure have discovered that        patients with a well-placed lead exhibit the anal sphincter        contraction and the bellow and toes responses in that        chronological order. Therefore, this specific chronological        order of these physiological responses can be used as an        indicator of how well the lead has been placed. In other words,        as the stimulation current amplitude is ramped up, if the        patient exhibits the anal sphincter contraction response first,        then the bellows response, followed by the toes response, then        there is a good likelihood that the lead has been placed        sufficiently well to provide adequate therapeutic relief for        sacral nerve stimulation. On the other hand, if the patient does        not exhibit one or more of the anal sphincter contraction        response, the bellows response, or the toes response, or if they        are exhibited out of order (e.g., toes response before bellows        response, or anal sphincter contraction response after either        the bellow response or the toes response), then it is likely        that the lead has not been placed well enough to provide        adequate therapeutic relief for sacral nerve stimulation, and        that repositioning of the lead may be necessary.

This specific sequence of the anal sphincter contraction response, thebellows response, and the toes response is not the only indicator of thelead placement. According to the present disclosure, the followingfactors may also indicate how well the lead has been placed:

-   -   1. A first value of a stimulation parameter (e.g., stimulation        current amplitude) corresponding to the anal sphincter response        should be below a predefined threshold;    -   2. A second value of the stimulation parameter corresponding to        the bellows response should be within a set of predefined        limits/boundaries as a function of the first value;    -   3. A third value of the stimulation parameter corresponding to        the toes response should also be within the set of predefined        limits/boundaries as a function of the first value;    -   4. The third value of the stimulation parameter corresponding to        the toes response should be within another set of predefined        limits/boundaries as a function of the second value.

The satisfaction (or not) of these factors can be graphicallyrepresented in FIG. 15 by a plot 1800 of stimulation amplitude (Y-axis)versus time (X-axis). The anal sphincter contraction response, thebellows response, and the toes response appear as distinct dots in theplot 1800, and each of them has a corresponding time (X-value) andstimulation amplitude (Y-value). As discussed above, the first test isthat the anal sphincter contraction and the bellows and toes responsesmust occur in the specific chronological sequence, which they do in theplot 1800. This is because the anal sphincter contraction response hasthe lowest X-value (indicating that it occurred first), the bellowsresponse has a greater X-value than the anal sphincter response(indicating that it occurred after the anal sphincter contractionresponse), and the toes response has an even greater X-value than thebellows response (indicating that it occurred after the bellowsresponse). This indicates that the lead placement satisfies one of thefactors to be considered optimized.

Another factor is that the anal sphincter contraction response should bebelow a predefined threshold 1810. The predefined threshold 1810corresponds to a stimulation amplitude value below which the analsphincter contraction response should occur. The rationale is that, ifthe lead placement has been optimized, then it should not take muchstimulation to evoke the anal sphincter contraction response. Stateddifferently, if the anal sphincter contraction response occurs too late(requiring a relatively large stimulation amplitude), this likelyindicates that the lead has not been well placed inside the patient'sbody, for example it may be too far from the target nerve, therebyneeding a high stimulation amplitude to actually trigger the analsphincter contraction response.

The numerical value of the predefined threshold 1810 may vary fromembodiment to embodiment. For example, in some embodiments, thepredefined threshold 1810 may be set to 2 mA. In that case, the leadplacement is considered not optimized unless the anal sphincter responseoccurs at a stimulation amplitude less than 2 mA. Regardless of thespecific value of the predefined threshold 1810, the anal sphinctercontraction response occurs below the threshold 1810 in the plot 1800,indicating that the lead placement satisfies another one of the factorsto be considered optimized.

Yet another factor is that the respective values of the stimulationparameter corresponding to the bellows response and the toes responseshould be within a set of predefined limits/boundaries as a function ofthe value of the stimulation parameter corresponding to the analsphincter contraction response. These predefined limits are illustratedin plot 1800 as an upper limit 1830 and a lower limit 1840. The upperlimit 1830 and the lower limit 1840 both originate from the analsphincter contraction response. In other words, they are functions ofthe anal sphincter contraction response. To satisfy this test, thebellows response and the toes response must each occur somewhere belowthe upper limit 1830 and above the lower limit 1840. The rationale forthis test is that, if the lead is placed well, then the bellows and toesresponses should each occur within a certain percentage of the analsphincter contraction response. For instance, if the anal sphinctercontraction response occurs at a first value of the stimulationamplitude, the bellows response occurs at a second value of thestimulation amplitude, and the toes response occurs at a third value ofthe stimulation amplitude, then the second and third values should eachbe greater than the first value (since the bellows and toes responsesshould occur later than the anal sphincter contraction response). In theplot 1800, the lower limit 1840 is set to the first value (where theanal sphincter contraction response occurs), and thus the bellows andtoes responses must each be greater than the lower limit 1840. On theother hand, if the lead is placed well, it should not take much morestimulation to trigger the bellows and toes responses after the analsphincter contraction response. This is graphically manifested in theplot 1800 by the bellows response and the toes response each being belowthe upper limit 1830.

The last factor is that the value of the stimulation parametercorresponding to the toes response should be within another set ofpredefined limits/boundaries as a function of the value of thestimulation parameter corresponding to the bellows response. Thesepredefined limits are illustrated in plot 1800 as an upper limit 1860and a lower limit 1870. The upper limit 1860 and the lower limit 1870both originate from the bellows response. In other words, they arefunctions of the bellows response. To satisfy this test, the toesresponse must occur somewhere below the upper limit 1860 and above thelower limit 1870. The rationale for this test is that, if the lead isplaced well, then the toes response should occur within a certainpercentage of the bellows response. For instance, if the bellowsresponse occurs at the second value of the stimulation amplitude, andthe toes response occurs at the third value of the stimulationamplitude, then the third value should be greater than the second value(since the toes response should occur later than the bellows response).In the plot 1800, the lower limit 1870 is set to the second value (wherethe bellows response occurs), and thus the toes response must be greaterthan the lower limit 1870. On the other hand, if the lead is placedwell, it should not take much more stimulation to trigger the toesresponse after the bellows response. This is graphically manifested inthe plot 1800 by the toes response being within the upper limit 1860.

Another consideration for setting the limits/boundaries 1830-1840 and1860-1870 is battery performance of the IPG. If the bellows and/or toesresponses deviate outside the limits 1830-1840, that could mean that thebattery performance of the IPG may be compromised, even if the patientmay receive otherwise satisfactory therapeutic relief from the pelvicstimulation. For example, if it takes a significantly greaterstimulation amplitude to trigger the bellows or toes responses than whatit takes to trigger the anal contraction response, this indicates thatthe present lead placement requires stronger-than-usual stimulation toprovide adequate therapeutic relief for the patient, which drains thebattery of the IPG faster than is otherwise necessary.

Another consideration for setting the limits/boundaries 1830-1840 and1860-1870 is electrode redundancy. In more detail, though the implantedlead has a plurality of electrodes, only a few are actually needed toprovide satisfactory electrical stimulation therapy. However, these“target” electrodes may migrate over time for various reasons. Whenelectrode migration occurs, the previous “target” electrode may nolonger provide satisfactory stimulation in the target nerve region.Consequently, one or more “back-up” electrodes may be needed to deliverthe electrical stimulation instead. However, for the “back-up”electrodes to satisfactorily replace the previous “target” electrode,the lead must be placed well enough. Again, the tests discussed above(e.g., whether the bellows and toes responses are within the limits1830-1840 and whether the toes response is within the limits 1860-1870)provide an indication of whether the lead has been implanted in aposition such that it can offer electrode redundancy when electrodemigration occurs.

It is understood that although the upper limits 1830 and 1860 appear asstraight lines (i.e., linear) in the plot 1800, either of them (or both)may actually be curved in other embodiments. For example, referring nowto FIG. 16 illustrating a plot 1800A, the upper limit 1830A (for boththe bellows and toes responses) and the upper limit 1860A (for the toesresponse) may each be curved instead of linear. However, the bellows andtoes responses still should be within the limits 1830A-1840 (and thetoes response should still be within the limits 1860A-1870) for the leadplacement to be considered optimized.

Referring now to FIG. 17, the user interface 1100 of the electronicprogrammer may display a plot similar to the plot 1800, so as tovisually inform the healthcare professional whether the lead placementhas been optimized based on the various tests discussed above. In theembodiment shown in FIG. 17, the anal sphincter contraction, bellows,and toes responses meet the specified chronological sequence. The analsphincter response is below the predefined threshold. The bellowsresponse is also within the upper and lower limits based on the analsphincter response. However, the toes response exceeds both the upperlimits based on the anal sphincter contraction response and the bellowsresponse. Therefore, the lead placement has not been optimized. The userinterface 1100 may display an example message informing the healthcareprofessional as follows: “Attention! Lead placement has not beenoptimized because the toes response is outside the acceptable limits.Please reposition the lead.” In some embodiments, as long as any of thetests discussed above is not satisfied, the lead placement is consideredto be not optimized, and the user interface 1100 may communicate that tothe healthcare professional through a suitable message.

In some embodiments, instead of (or in addition to) providing agraphical illustration of whether the tests discussed above are met, theuser interface may highlight problems as (or after) the physiologicalresponses are recorded. For example, referring to FIG. 18, thehealthcare professional may record the physiological responses via theuser interface 1100 of the electronic programmer, for example the analsphincter contraction response as the first response, the bellowsresponse as the second response, and the toes response as the thirdresponse. The anal sphincter contraction response occurs at 1 mA ofstimulation current, which is fine. Therefore, it is highlighted ingreen (or not highlighted at all in alternative embodiments). Based onthis information, the electronic programmer may automatically calculatethe limits (such as the limits 1830-1840 discussed above) for thebellows and toes responses. If the lead has been placed well, then thebellows and toes responses should be within these limits calculated as afunction of the anal sphincter contraction response.

The bellows response occurs after the anal sphincter contractionresponse, which meets the chronological sequence test discussed above.However, suppose that the upper limit for the bellows response is at150% of the anal sphincter contraction stimulation current, which inthis case would be 1 mA×150%=1.5 mA. Here, the bellows response occursat 1.4 mA, which is approaching the upper limit of 1.5 mA. As such, thebellows response is highlighted as yellow, because it indicates apotential problem with the lead placement, or at least that the leadplacement most likely has not been optimized.

Also, based on the bellows response, the electronic programmer mayautomatically calculate the limits (such as the limits 1860-1870discussed above) for the toes response. If the lead has been placedwell, then the toes response should be within these limits calculated asa function of the bellows response, as well as within the limitscalculated as a function of the anal sphincter contraction response.

As shown in FIG. 18, the toes response occurs after the bellowsresponse, which meets the chronological sequence test discussed above.Suppose the upper limit calculated as a function of the anal sphinctercontraction response is at 200% of the anal sphincter contractionstimulation current (which would be 1 mA×200%=2.0 mA), and that theupper limit calculated as a function of the bellows response is at 150%of the bellows response stimulation current (which would be 1.4mA×150%=2.1 mA). Here, the toes response occurs at 5.0 mA, which exceedsboth the upper limit calculated as a function of the anal sphinctercontraction response and as a function of the bellows response, whichare 2.0 mA and 2.1 mA, respectively. As such, the toes response ishighlighted as red, as it indicates a definite problem with the leadplacement. In other words, had the lead placement been optimized, thetoes response would not have exceeded the limits derived based on theanal sphincter contraction response and the bellows response. The redhighlighting of the toes response immediately informs the healthcareprofessional that the lead should be repositioned before the stimulationtherapy can be expected to achieve satisfactory results. In someembodiments, the electronic programmer may display a message similar tothat shown in FIG. 17 to inform the healthcare professional what theproblem is, and that the lead should be repositioned accordingly.

FIG. 19 is a flowchart illustrating a method 2000 of evaluating aplacement of a lead configured to deliver an electrical stimulationtherapy for a patient. In some embodiments, the steps of the method 2000are performed by a portable electronic device, for example the clinicianprogrammer discussed above with reference to FIGS. 2B and 7.

The method 2000 includes a step 2010 of programming a pulse generator(e.g., an IPG or an EPG) to generate electrical stimulation to target asacral nerve or a pudendal nerve of the patient. The electricalstimulation can be delivered at least in part via a lead that isconfigured to be coupled to the pulse generator. The electricalstimulation is applied by including ramping up a stimulation parameterover time.

The method 2000 includes a step 2020 of detecting a first physiologicalresponse, a second physiological response, and a third physiologicalresponse from the patient as a result of the electrical stimulation. Insome embodiments, the detecting step 2020 comprises detecting an analsphincter contraction response as the first physiological response,detecting a bellows response as the second physiological response, anddetecting a toes response as the third physiological response.

The method 2000 includes a step 2030 of measuring a first value of thestimulation parameter associated with the first physiological response,a second value of the stimulation parameter associated with the secondphysiological response, and a third value of the stimulation parameterassociated with the third physiological response.

The method 2000 includes a step 2040 of evaluating a placement of thelead inside the patient based on at least one of: a chronologicalsequence in which the first, second, and third physiological responsesoccurred, a comparison of the first value with a predeterminedthreshold, or respective deviations of the second value or the thirdvalue from the first value. In some embodiments, the evaluating theplacement of the lead further comprises: determining that the placementof the lead has not been optimized unless the first value is below thepredefined threshold. In some embodiments, the evaluating the placementof the lead comprises determining that the placement of the lead has notbeen optimized unless the anal sphincter contraction response occurredbefore the bellows response, and the bellow response occurred before thetoes response. In some embodiments, the evaluating the placement of thelead comprises determining that the placement of the lead has not beenoptimized unless: the respective deviations of the second value or thethird value from the first value are within a first set of predefinedboundaries; and the deviation of the third value from the second valueis within a second set of predefined boundaries.

The method 2000 includes a step 2050 of recommending, in response to adetermination that the placement of the lead has not been optimized, arepositioning of the lead.

It is understood that some of the steps 2010-2050 need not necessarilybe performed sequentially unless otherwise specified. It is alsounderstood that the method 2000 may include additional steps may beperformed before, during, or after the steps 2010-2050. For example, themethod 2000 may include a step of displaying, via a graphicalrepresentation, the first, second, and third values and at least one of:the predefined threshold, the first set of predefined boundaries, andthe second set of predefined boundaries.

The foregoing has outlined features of several embodiments so that thoseskilled in the art may better understand the detailed description thatfollows. Those skilled in the art should appreciate that they mayreadily use the present disclosure as a basis for designing or modifyingother processes and structures for carrying out the same purposes and/orachieving the same advantages of the embodiments introduced herein.Those skilled in the art should also realize that such equivalentconstructions do not depart from the spirit and scope of the presentdisclosure, and that they may make various changes, substitutions andalterations herein without departing from the spirit and scope of thepresent disclosure.

What is claimed is:
 1. A method of evaluating a placement of a leadconfigured to deliver an electrical stimulation therapy for a patient,comprising: programming a pulse generator to generate electricalstimulation to target a sacral nerve or a pudendal nerve of the patient,the electrical stimulation being delivered at least in part via a lead,the electrical stimulation being applied by ramping up a stimulationparameter over time; detecting, via an observation by a healthcareprofessional or via feedback provided by the patient, a firstphysiological response, a second physiological response, and a thirdphysiological response from the patient as a result of the electricalstimulation; measuring a first value of the stimulation parameterassociated with the first physiological response, a second value of thestimulation parameter associated with the second physiological response,and a third value of the stimulation parameter associated with the thirdphysiological response; and evaluating a placement of the lead insidethe patient based on at least one of: a chronological sequence in whichthe first, second, and third physiological responses occurred, acomparison of the first value with a predetermined threshold, orrespective deviations of the second value or the third value from thefirst value.
 2. The method of claim 1, further comprising: recommending,in response to a determination that the placement of the lead has notbeen optimized, a repositioning of the lead.
 3. The method of claim 1,wherein the detecting comprises detecting an anal sphincter contractionresponse as the first physiological response, detecting a bellowsresponse as the second physiological response, and detecting a toesresponse as the third physiological response.
 4. The method of claim 3,wherein the evaluating the placement of the lead further comprisesdetermining that the placement of the lead has not been optimizedunless: the first value is below the predetermined threshold; and theanal sphincter contraction response occurred before the bellowsresponse, and the bellow response occurred before the toes response. 5.The method of claim 3, wherein the evaluating the placement of the leadcomprises determining that the placement of the lead has not beenoptimized unless: the respective deviations of the second value or thethird value from the first value are within a first set of predefinedboundaries; and the deviation of the third value from the second valueis within a second set of predefined boundaries.
 6. The method of claim5, further comprising: displaying, via a graphical representation, thefirst, second, and third values and at least one of: the predeterminedthreshold, the first set of predefined boundaries, and the second set ofpredefined boundaries.
 7. The method of claim 1, wherein theprogramming, the detecting, and the measuring are performed while thepatient is sedated.
 8. A method, comprising: applying, at least in partvia a lead, an electrical stimulation to a patient by increasing astimulation parameter over time; detecting, via an observation by ahealthcare professional or via feedback provided by the patient, an analsphincter response, a bellows response, and a toes response from thepatient as a result of the electrical stimulation; determining a firstvalue of the stimulation parameter associated with the anal sphincterresponse, a second value of the stimulation parameter associated withthe bellows response, and a third value of the stimulation parameterassociated with the toes response; and evaluating a placement of thelead inside the patient based on: a chronological occurrence of the analsphincter response, the bellows response, and the toes response; acomparison of the first value with a predetermined threshold; adeviation of the second value from the first value; a deviation of thethird value from the first value; or a deviation of the third value fromthe second value.
 9. The method of claim 8, wherein the anal sphincterresponse, the bellows response, and the toes response are detected whilethe patient is sedated.
 10. The method of claim 8, wherein the applyingthe electrical stimulation comprises applying the electrical stimulationto a sacral nerve or a pudendal nerve of the patient.
 11. The method ofclaim 8, wherein the evaluating comprises determining that the placementof the lead has not been optimized when either the bellows response orthe toes response occurred before the anal sphincter response.
 12. Themethod of claim 8, wherein the evaluating comprises determining that theplacement of the lead has not been optimized when the toes responseoccurred before the bellows response.
 13. The method of claim 8, whereinthe evaluating comprises determining that the placement of the lead hasnot been optimized when the first value exceeds the predeterminedthreshold.
 14. The method of claim 8, wherein the evaluating comprisesdetermining that the placement of the lead has not been optimized whenthe deviation of the second value from the first value is outside of aset of predefined boundaries.
 15. The method of claim 8, wherein theevaluating comprises determining that the placement of the lead has notbeen optimized when the deviation of the third value from the secondvalue is outside of a set of predefined boundaries.
 16. The method ofclaim 8, wherein the evaluating comprises determining that the placementof the lead has not been optimized when the deviation of the third valuefrom the second value is outside of a set of predefined boundaries. 17.A method, comprising: delivering, via a lead implanted inside a patient,a electrical stimulation to a sacral nerve or a pudendal nerve of thepatient by gradually increasing a value of a stimulation parameter overtime; observing, by a healthcare professional or via feedback providedby the patient, an anal sphincter response, a bellows response, and atoes response from the patient as a result of the electricalstimulation; and determining whether the lead has been well-placedinside the patient based on an observed timing of the anal sphincterresponse, the bellows response, and the toes response.
 18. The method ofclaim 17, wherein the delivering and the observing are performed whilethe patient is in a sedated state.
 19. The method of claim 17, whereinthe determining comprises determining that the lead has not beenwell-placed when either the bellows response or the toes responseoccurred before the anal sphincter response, or when the toes responseoccurred before the bellows response.
 20. The method of claim 17,further comprising: measuring a first value of the stimulation parameterwhen the anal sphincter response occurred; measuring a second value ofthe stimulation parameter when the bellows response occurred; andmeasuring a third value of the stimulation parameter when the toesresponse occurred; wherein the determining is further based on: acomparison between the first value and a predetermined threshold; acomparison between the first value and the second value; a comparisonbetween the first value and the third value; or a comparison between thesecond value and the third value.